Thursday, September 25, 2014

The Vaccine Adverse Events Reporting System


 
In 1990, the Vaccine Adverse Event Report System (VAERS) was created by the Center for Disease Control (CDC) and the Food and Drug Administration (FDA). Medical professionals are required to report and adverse events to the system and concerned parents can also report via fax, mail, or online. The system’s purpose is to be a “post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States,” (according to the VAERS itself).

Anti-vaccine proponents use data from the VAERS database to claim that there is scientific evidence for the risks they claim. 10-15% of adverse events reported are for "serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been caused by a vaccine." However, according to skepticalraptor.com, “The data is considered to be ‘passive’ because the individual reports can be made online, by fax or by mail–real causal events may be underreported and hyped, imaginary issues with no causality, can be over-reported. However, without medical investigations of causality between the vaccination and the claimed adverse events that are reported to the VAERS database, the data have no real value.” Therefore, the data cannot prove causality.

Not only is the data passive, the reporting system is particularly flawed. Dr. Laidler reported,

“The chief problem with the VAERS data is that reports can be entered by anyone and are not routinely verified. To demonstrate this, a few years ago I entered a report that an influenza vaccine had turned me into The Hulk. The report was accepted and entered into the database.”

Dr. Laider literally told the VAERS that the vaccine turned him into the Hulk and they had to report it. Since this adverse event is rather unusual, the VAERS called Laidler to ask for details. After explaining it, Laidler gave permission for the report to be removed from the database. If he had refused permission, the VAERS would have been obligated to keep the bogus report.

Anti-vaxxers have claimed Dr. Laidler’s experiment a hoax and maintain that the VAERS collects accurate data. In response, a few people have gone ahead and tried similar things. Such as this man in the UK,

“VAERS has a helpful popup which tells you exactly what it needs to know – which are the most important pieces of data it needs. However, the fact that I live in the UK was not deemed of importance. Neither was the fact that I told VAERS that my daughter had been turned into Wonder Woman. The only piece of contact data I submitted was my email address and I wasn’t even asked for that. I submitted it voluntarily...

The Javascript routine caught the fact that I tried to submit an adverse event *before* the fictional date of my daughter’s birth but it failed to catch that I stated the vaccine was administered at 18months and that the date for vaccination I provided was only 6 months after the ‘birth’ date.”

So if this man in the UK can find that many flaws in our system and record himself doing it, what’s to keep the data truthful? The answer: nothing. People using data from the VAERS must take the majority of the information with a grain of salt or find a completely different source. Well, then what’s the point of having the VAERS at all?

The VAERS is a tool that was created for two reasons. First, it appeases the anti-vaccination crowd, and second, the system can be used for observing data to form a hypothesis about the effects of vaccines. In addition, the VAERS has the power to report its findings to the CDC. The CDC can then use that information to more effectively shape policies. The recent issues with the rotavirus vaccine have proven where the real importance of the VAERS lies.

The rotavirus vaccine is an oral vaccine given to children under 5. Two main types of this vaccine are given Rotarix and RotaTeq. The difference between these two is mainly the packaging.

As you can see, Rotarix looks much more like a syringe that a nurse would inject. In 33 of 39 cases reported to the VAERS, the nurses did mistake the oral vaccine for a shot. Luckily, the children were not hurt by this mistake, but the vaccine does nothing when injected this way. The VAERS reported the delivery errors to the CDC which now reminds health professionals about proper delivery of the vaccines. Therein lies the purpose people should focus on, not the easily skewed data.

Sources:
http://www.skepticalraptor.com/skepticalraptorblog.php/reports-vaccine-related-effects/
http://antiantivax.flurf.net/#VAERS
http://leftbrainrightbrain.co.uk/2006/03/14/on-using-vaers/
http://vaccines.procon.org/
http://vaers.hhs.gov/index

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